NDC 83027-0044 Addex
Lappa Major, Plantago Major, Taraxacum Officinale, Glyphosate Spray Oral

Product Information

What is NDC 83027-0044?

The NDC code 83027-0044 is assigned by the FDA to the product Addex which is a human over the counter drug product labeled by Nutritional Specialties, Inc.. The generic name of Addex is lappa major, plantago major, taraxacum officinale, glyphosate. The product's dosage form is spray and is administered via oral form. The product is distributed in a single package with assigned NDC code 83027-0044-1 60 ml in 1 bottle, spray . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code83027-0044
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Addex
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Lappa Major, Plantago Major, Taraxacum Officinale, Glyphosate
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Arctium Lappa Root; Glyphosate; Plantago Major Whole; Taraxacum Officinale
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormSpray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Nutritional Specialties, Inc.
Labeler Code83027
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		02-24-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Addex?


Product Packages

NDC Code 83027-0044-1

Package Description: 60 mL in 1 BOTTLE, SPRAY

Product Details

What are Addex Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Addex Active Ingredients UNII Codes

Addex Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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Addex Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients:



Lappa Major 3X, Plantago Major 3X, Taraxacum Officinale 3X, Glyphosate 12C.


Purpose:



Aids in temporary relief of symptoms from pesticide exposure such as itching, hives, nasal congestion, muscle weakness, irritabitity, headaches, gastrointestinal upset and difficulty sleeping.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Warnings:



Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening


Keep Out Of Reach Of Children:



KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.


Directions:



Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.


Indications:



Aids in temporary relief of symptoms from pesticide exposure such as itching, hives, nasal congestion, muscle weakness, irritabitity, headaches, gastrointestinal upset and difficulty sleeping.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Inactive Ingredients:



Alcohol USP 20%, Purified Water USP.


Questions:



MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com


Package Label Display:



Professional

Health Products

HOMEOPATHIC

NDC 83027-0044-1

ADDEX

2 FL. OZ (60 ml)


* Please review the disclaimer below.